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NCT04975997 (iberdomide in Relapsed or Refractory Multiple Myeloma): BVCT ex-ante prediction vs. reported outcome

On 4 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 23 Sep 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (MRD negativity/ORR) and commercially TBD.

Clinical Trial

Acronym
EXCALIBER-RRMM
Drug Name
iberdomide
Drug MoA
cereblon E3 ligase modulator that degrades IKZF1 and IKZF3
Drug Modality
molecular glue degrader
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Relapsed or Refractory Multiple Myeloma
Human Patients
864
Sponsor
Bristol Myers Squibb
Phase
Phase 3

Prediction of , index 1936

Prospective Prediction
Prediction Index
1936
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit to daratumumab + dexamethasone (Iber-Dd) in OS moderately superior bortezomib + daratumumab + dexamethasone (DVd) and slightly superior to belantamab mafodotin + pomalidomide + dexamethasone(BPd))
Technical Prediction
SUCCESS (statistically significant additive clinical benefit to daratumumab + dexamethasone (Iber-Dd) in ORR/PFS moderately superior to bortezomib + daratumumab + dexamethasone (DVd) and non-superior-non-inferior to belantamab mafodotin + pomalidomide + dexamethasone(BPd))

Readout of

Prediction Validation
Readout Date
Prediction To Readout
172 days in advance
Readout Data Interpretation
iberdomide in combination with daratumumab and dexamethasone (IberDd) achieved a statistically significant superiority in MRD negativity (a deeper assessment than ORR) compared with the central arm of daratumumab/bortezomib/dexamethasone (DVd); wait for OS data
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (MRD negativity/ORR) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
Phase
Phase 3
Status
Active not recruiting
Enrollment
939
Lead sponsor
Celgene
Conditions
Multiple Myeloma
Interventions
DRUG: Dexamethasone; DRUG: Daratumumab; DRUG: Bortezomib; DRUG: Iberdomide; DRUG: Iberdomide; DRUG: Iberdomide; DRUG: Dexamethasone; DRUG: Daratumumab
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-06-23
Primary completion
2027-11-16
Completion
2032-06-25
Primary outcomes
  • Progression-free Survival (PFS) (Up to approximately 5 years)
  • Minimal Residual Disease (MRD) negative Complete Response (CR) at any time (Up to approximately 5 years)

NCT04975997 on ClinicalTrials.gov

How to read these records: evidence · methodology · all trials